Aminocaproic acid injection and preparation method thereof

Abstract

The invention discloses an aminocaproic acid injection and a preparation method thereof. The method comprises the following steps: (1) adding freshly boiled water for injection with a preparation amount of 50% into a concentrated preparation tank, adding aminocaproic acid, and stirring to dissolve; Use Suzhou sand stick to filter back until clear, then filter into the dilute tank; (2) Add water for injection to the full amount, stir for 15 minutes to make it uniform, and adjust the pH; (3) Use Suzhou sand filter stick, 0.45μm and 0.22 μm polyethersulfone fin back filtration until clear; (4) sampling test intermediate content and pH value, after each item is qualified, the liquid medicine is filtered into the liquid storage tank; (5) The liquid medicine in the liquid storage tank is passed through several times After filtering with a 0.22 μm polyethersulfone fin, it is input into a filling buffer tank for filling; (6) potting; (7) sterilizing, the sterilization temperature is 100° C., and the time is 30 minutes. The invention adopts secondary sterilization and filtration, the whole process is aseptic, reduces the visible foreign matters of medicines, and ensures the product quality.

Description

technical field [0001] The invention relates to an aminocaproic acid injection and a preparation method thereof. Background technique [0002] Aminocaproic acid is an antifibrinolytic drug. Fibrinogen specifically binds to fibrin through the lysine binding site in its molecular structure, and then becomes plasmin under the action of an activator, which can cleave the arginine and lysine peptide chains in fibrin , forming fibrin degradation products that dissolve blood clots. The chemical structure is similar to lysine, which can qualitatively inhibit the combination of plasminogen and fibrin, prevent its activation, thereby inhibiting fibrinolysis, and high concentration (100mg / L) can directly inhibit the activity of plasmin and achieve hemostatic effect. Aminocaproic acid injection is suitable for the prevention and treatment of various bleeding caused by hyperfibrinolysis. However, the existing aminocaproic acid injection contains foreign matter, which affects product q...

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to overcome the defects that the existing aminocaproic acid injection contains foreign matter and the product quality is not high, and provides a kind of aminocaproic acid injection and its preparation method